RAPS

IMDRF publishes regulatory reliance playbook, document on selecting adverse event terminologies

The International Medical Device Regulators Forum (IMDRF) has published two new documents to help regulators and sponsors harmonize adverse event terminology and support regulatory reliance across ...
Mena FN

3Analytics Partners With Assurx To Revolutionize IMDRF Coding Using AI

(MENAFN- EIN Presswire) The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring compliance with EU MDR and FDA guidelines while reducing costs by up to 72%. Having an eQMS software ...
JD Supra

FDA Delays eMDR System Adverse Event Codes Update

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply. The ...
RAPS

CDRH Ushers in Changes to Device Submission System with Test Sandbox

The electronic system for medical device submissions to the US Food and Drug Administration’s (FDA) main gateway is set to go through a series of major coding changes, which were kicked off with a new ...